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FDA Orange Book · active-ingredient family

Methylphenidate hydrochloride

Methylphenidate hydrochloride is approved as 13 brand and 72 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:RELEXXII · NDA 216117

13

Brand (NDA)

72

Generics (ANDA)

49

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, for suspension, extended release, solution, tablet, tablet, chewable, tablet, extended release, tablet, extended release, chewable

ProductApplicantApplicationTEApproved
RELEXXIIRLD×7OSMOTICA PHARM USNDA 216117—Jun 23, 2022
ADHANSIA XRRLD×6KNOA PHARMANDA 212038—Feb 27, 2019
JORNAY PMRLD×5IRONSHORE PHARMSNDA 209311—Aug 08, 2018
QUILLICHEW ERRLD×3NEXTWAVE PHARMSNDA 207960—Dec 04, 2015
APTENSIO XRRLD×7RHODES PHARMSNDA 205831AB3Apr 17, 2015
QUILLIVANT XRRLDNEXTWAVENDA 202100ABSep 27, 2012
RITALIN LARLD×5SANDOZNDA 021284AB1Apr 10, 2004
METADATE CDRLD×6AYTU BIOPHARMANDA 021259AB2May 27, 2003
METHYLINRLD×3SPECGX LLCNDA 021475—Apr 15, 2003
METHYLINRLD×2SPECGX LLCNDA 021419AADec 19, 2002
CONCERTARLD×4JANSSEN PHARMSNDA 021121ABAug 01, 2000
RITALIN-SRRLDNOVARTISNDA 018029—Mar 30, 1982
RITALINRLD×3SANDOZNDA 010187ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (72)

ProductApplicantApplicationTEApproved
METHYLPHENIDATE HYDROCHLORIDESUN PHARM INDS INCANDA 217229ABAug 25, 2023
METHYLPHENIDATE HYDROCHLORIDE×4ALKEM LABS LTDANDA 214447ABMay 23, 2023
METHYLPHENIDATE HYDROCHLORIDE×4RHODES PHARMSANDA 214111—May 31, 2022
METHYLPHENIDATE HYDROCHLORIDE×2ASCENT PHARMS INCANDA 207417AAJan 29, 2021
METHYLPHENIDATE HYDROCHLORIDE×2CHARTWELL MOLECULARANDA 207414—Dec 16, 2020
METHYLPHENIDATE HYDROCHLORIDE×3ACCORD HLTHCAREANDA 213936ABOct 28, 2020
METHYLPHENIDATE HYDROCHLORIDEALKEM LABS LTDANDA 212288ABOct 06, 2020
METHYLPHENIDATE HYDROCHLORIDE×4SUN PHARM INDS INCANDA 205135ABAug 19, 2020
METHYLPHENIDATE HYDROCHLORIDE×4GRANULESANDA 213473ABJul 29, 2020
METHYLPHENIDATE HYDROCHLORIDE×3PRINSTON INCANDA 212697ABJul 23, 2020
METHYLPHENIDATE HYDROCHLORIDE×2QUAGENANDA 213567AAJun 04, 2020
METHYLPHENIDATE HYDROCHLORIDE×2ANDA REPOSITORYANDA 210764AAApr 10, 2020
METHYLPHENIDATE HYDROCHLORIDE×2ALKEM LABS LTDANDA 211647AAMar 30, 2020
METHYLPHENIDATE HYDROCHLORIDE×3ALKEM LABS LTDANDA 211779ABOct 04, 2019
METHYLPHENIDATE HYDROCHLORIDE×4ASCENT PHARMS INCANDA 211009ABSep 03, 2019
METHYLPHENIDATE HYDROCHLORIDE×2STRIDES PHARMA INTLANDA 204659—Jul 15, 2019
METHYLPHENIDATE HYDROCHLORIDE×5GRANULESANDA 211796AB1May 23, 2019
METHYLPHENIDATE HYDROCHLORIDE×4ANDOR PHARMSANDA 211918ABApr 24, 2019
METHYLPHENIDATE HYDROCHLORIDE×3CEDIPROF INCANDA 208737ABFeb 01, 2019
METHYLPHENIDATE HYDROCHLORIDE×7ACTAVIS ELIZABETHANDA 208861AB3Dec 13, 2018
METHYLPHENIDATE HYDROCHLORIDE×4ALVOGENANDA 210818—Nov 30, 2018
METHYLPHENIDATE HYDROCHLORIDE×2GRANULESANDA 210992ABNov 21, 2018
METHYLPHENIDATE HYDROCHLORIDE×3AUROLIFE PHARMA LLCANDA 209276—Oct 25, 2018
METHYLPHENIDATE HYDROCHLORIDE×2HIBROW HLTHCAREANDA 210139AAOct 03, 2018
METHYLPHENIDATE HYDROCHLORIDEACTAVIS LABS FL INCANDA 206049ABMay 17, 2018
METHYLPHENIDATE HYDROCHLORIDE×3ACTAVIS LABS FLANDA 076772ABMar 22, 2018
METHYLPHENIDATE HYDROCHLORIDE×2ACTAVIS LABS FLANDA 076655ABMar 21, 2018
METHYLPHENIDATE HYDROCHLORIDE×3BIONPHARMAANDA 209753ABMar 02, 2018
METHYLPHENIDATE HYDROCHLORIDEDR REDDYS LABS SAANDA 200886AB1Feb 26, 2018
METHYLPHENIDATE HYDROCHLORIDE×4AMNEAL PHARMSANDA 207515—Feb 01, 2018
METHYLPHENIDATE HYDROCHLORIDE×3ASCENT PHARMS INCANDA 210354ABDec 29, 2017
METHYLPHENIDATE HYDROCHLORIDE×5OSMOTICA PHARM USANDA 205327ABJul 28, 2017
METHYLPHENIDATE HYDROCHLORIDE×4ANI PHARMSANDA 208607—Jul 14, 2017
METHYLPHENIDATE HYDROCHLORIDE×3ABHAI LLCANDA 206932ABMay 11, 2017
METHYLPHENIDATE HYDROCHLORIDE×3MPP PHARMAANDA 207587—Mar 03, 2017
METHYLPHENIDATE HYDROCHLORIDE×3QUAGENANDA 204954—Jan 26, 2017
METHYLPHENIDATE HYDROCHLORIDE×2ABHAI LLCANDA 207485AANov 18, 2016
METHYLPHENIDATE HYDROCHLORIDE×3RISINGANDA 205756ABNov 07, 2016
METHYLPHENIDATE HYDROCHLORIDE×4AUROLIFE PHARMA LLCANDA 206726ABOct 21, 2016
METHYLPHENIDATE HYDROCHLORIDE×3ALVOGENANDA 206840—Sep 15, 2016
METHYLPHENIDATE HYDROCHLORIDE×6IMPAX LABS INCANDA 205105AB2Jul 28, 2016
METHYLPHENIDATE HYDROCHLORIDE×2ALVOGENANDA 204772—Feb 29, 2016
METHYLPHENIDATE HYDROCHLORIDE×3NOVEL LABS INCANDA 207884ABNov 13, 2015
METHYLPHENIDATE HYDROCHLORIDE×6SPECGX LLCANDA 203583AB2Sep 29, 2015
METHYLPHENIDATE HYDROCHLORIDE×3ASCENT PHARMS INCANDA 207416ABSep 22, 2015
METHYLPHENIDATE HYDROCHLORIDE×2NOVEL LABS INCANDA 204602AAAug 14, 2015
METHYLPHENIDATE HYDROCHLORIDE×2ABHAI LLCANDA 207488ABJun 09, 2015
METHYLPHENIDATE HYDROCHLORIDE×3NOVEL LABS INCANDA 204115—Feb 25, 2015
METHYLPHENIDATE HYDROCHLORIDE×4BARR LABS INCANDA 079031—Oct 15, 2014
METHYLPHENIDATE HYDROCHLORIDE×3OXFORD PHARMSANDA 202892ABSep 23, 2014
METHYLPHENIDATE HYDROCHLORIDE×3MOUNTAINANDA 091159—Mar 12, 2014
METHYLPHENIDATE HYDROCHLORIDE×2NOVITIUM PHARMAANDA 201466—Nov 12, 2013
METHYLPHENIDATE HYDROCHLORIDE×4LANNETT CO INCANDA 091695BXJul 09, 2013
METHYLPHENIDATE HYDROCHLORIDE×3SPECGX LLCANDA 202608BXDec 28, 2012
METHYLPHENIDATE HYDROCHLORIDE×3TEVA PHARMSANDA 077707AB2Jul 19, 2012
METHYLPHENIDATE HYDROCHLORIDE×3TEVA PHARMSANDA 078873—Jul 19, 2012
METHYLPHENIDATE HYDROCHLORIDE×3SUN PHARM INDS INCANDA 090710ABMar 15, 2012
METHYLPHENIDATE HYDROCHLORIDE×4DR REDDYS LABS SAANDA 078458AB1Dec 01, 2011
METHYLPHENIDATE HYDROCHLORIDE×2TRIS PHARMA INCANDA 091601AAJul 23, 2010
METHYLPHENIDATE HYDROCHLORIDE×3ACTAVIS ELIZABETHANDA 040321—Feb 05, 2002
METHYLPHENIDATE HYDROCHLORIDEHERITAGE PHARMAANDA 075450—Dec 21, 2001
METHYLPHENIDATE HYDROCHLORIDEABLEANDA 076032—May 09, 2001
METHYLPHENIDATE HYDROCHLORIDE×3ABLEANDA 040404—Mar 29, 2001
METHYLPHENIDATE HYDROCHLORIDEWATSON LABSANDA 040410—Feb 09, 2001
METHYLIN ER×2SPECGX LLCANDA 075629ABMay 09, 2000
METADATE ERLANNETT CO INCANDA 040306—Oct 20, 1999
METHYLPHENIDATE HYDROCHLORIDE×3SPECGX LLCANDA 040300ABNov 27, 1998
METHYLPHENIDATE HYDROCHLORIDE×3WATSON LABSANDA 040220—Aug 29, 1997
METADATE ERLANNETT CO INCANDA 089601—Jun 01, 1988
METHYLPHENIDATE HYDROCHLORIDELANNETT CO INCANDA 086429—Approved Prior to Jan 1, 1982
METHYLPHENIDATE HYDROCHLORIDELANNETT CO INCANDA 085799—Approved Prior to Jan 1, 1982
METHYLPHENIDATE HYDROCHLORIDELANNETT CO INCANDA 086428—Approved Prior to Jan 1, 1982

Listed patents (49)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8202537Mar 15, 2027in 9 mo
Product
8062667Mar 29, 2029in 2 yr 10 mo
Product
8465765Feb 15, 2031in 4 yr 9 mo
ProductU-1415
8778390Feb 15, 2031in 4 yr 9 mo
ProductU-1543
8956649Feb 15, 2031in 4 yr 9 mo
ProductU-1665
8563033Feb 15, 2031in 4 yr 9 mo
ProductU-1415
9040083Feb 15, 2031in 4 yr 9 mo
Product
8287903Feb 15, 2031in 4 yr 9 mo
Product
10292937Mar 23, 2032in 5 yr 10 mo
U-2357
9603809Mar 23, 2032in 5 yr 10 mo
U-2357
8916588Mar 23, 2032in 5 yr 10 mo
U-2357
9028868Mar 23, 2032in 5 yr 10 mo
U-2357
10617651Mar 23, 2032in 5 yr 10 mo
U-2357
9034902Mar 23, 2032in 5 yr 10 mo
U-2357
10881618Mar 23, 2032in 5 yr 10 mo
U-2357
11911518Mar 23, 2032in 5 yr 10 mo
U-2357
11241391Mar 23, 2032in 5 yr 10 mo
U-2357
11241392Mar 23, 2032in 5 yr 10 mo
Product
9498447Mar 23, 2032in 5 yr 10 mo
Product
9283214Mar 23, 2032in 5 yr 10 mo
Product
9023389Mar 23, 2032in 5 yr 10 mo
Product
10905652Mar 23, 2032in 5 yr 10 mo
Product
8927010Mar 23, 2032in 5 yr 10 mo
Product
10182995Mar 23, 2032in 5 yr 10 mo
Product
9295642Aug 14, 2033in 7 yr 3 mo
ProductU-1827
11103495Aug 14, 2033in 7 yr 3 mo
ProductU-2993
9545399Aug 14, 2033in 7 yr 3 mo
ProductU-1827
9844544Aug 14, 2033in 7 yr 3 mo
ProductU-2203
10857143Aug 14, 2033in 7 yr 3 mo
ProductU-2993
11103494Aug 14, 2033in 7 yr 3 mo
Product
8999386Aug 14, 2033in 7 yr 3 mo
Product
11633389Aug 14, 2033in 7 yr 3 mo
Product
10292939Oct 30, 2035in 9 yr 6 mo
ProductU-2357
10512613Oct 30, 2035in 9 yr 6 mo
U-2357
10449159Oct 30, 2035in 9 yr 6 mo
U-2357
10500162Oct 30, 2035in 9 yr 6 mo
U-2357
10568841Oct 30, 2035in 9 yr 6 mo
ProductU-2357
10111839Oct 30, 2035in 9 yr 6 mo
U-2357
10292938Oct 30, 2035in 9 yr 6 mo
Product
10507186Oct 30, 2035in 9 yr 6 mo
Product
10688060Oct 30, 2035in 9 yr 6 mo
Product
10512612Oct 30, 2035in 9 yr 6 mo
Product
9974752Oct 30, 2035in 9 yr 6 mo
Product
10695336Feb 03, 2037in 10 yr 9 mo
U-4032
10265308Feb 03, 2037in 10 yr 9 mo
ProductU-4032
9855258Feb 03, 2037in 10 yr 9 mo
ProductU-4032
9827234Feb 03, 2037in 10 yr 9 mo
U-4032
9707217Feb 03, 2037in 10 yr 9 mo
Product
10722473Nov 19, 2038in 12 yr 7 mo
U-2357

Methylphenidate hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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